In human females, the pelvic floor muscles may become weak or lose conditioning as the result of age, childbirth, injury or disease. As a result, those with weak or unconditioned muscles may experience difficulty controlling or stopping the flow of urine. As a result, these individuals may experience episodes of incontinence, sexual dysfunction, or other undesirable situations related to muscle control. In order to improve the condition of the pelvic floor muscles and thus reduce the incidences of incontinence, improve sexual function, and/or improve other undesirable situations, individuals may perform various exercises including an exercise that involves the voluntary contraction of the pelvic floor muscles. The most well-known of these is the Kegel exercise. When performing Kegel exercises, a subject generally will attempt to contract their muscles for a short period of time, release the contraction of those muscles and then repeat this process. The desired result is the improvement of muscle tone in the pelvic floor muscles. Some individuals may have difficulty identifying the correct muscles to contract or may not hold the contraction long enough to be beneficial. In other cases, the individual may not remember to perform the exercises or lose interest and either stop performing the exercise or not perform them frequently enough to obtain a desired benefit.
There have been devices disclosed that assist a user in their efforts to learn to contract the muscles of the pelvic floor using various methods of electrically stimulating those muscles. In fact, various classes of muscle stimulators have been defined by the U.S. Food and Drug Administration including muscle stimulators for the improvement of muscle tone, muscle stimulators for the treatment of incontinence and stimulation for the treatment of muscle pain. Devices for facilitating some of these treatments are also known in the art. For example, U.S. Pat. No. 5,800,501 (Sherlock) discloses a device for providing an electrode for electrical stimulation. This same device may also be used to receive biofeedback signals. With such a device, a user may receive stimulation in order to strengthen the muscles of the pelvic floor. In addition to the stimulation portions, Sherlock also discloses a biofeedback portion. The biofeedback portion may be used to measure a user's muscle activity in response to such stimulation or as the result of exercises initiated by the user. Such a device may be of value to a user who desires to strengthen their pelvic floor muscles by combining stimulation with self-initiated muscle exercise. A user of such a device must be diligent with regard to their self-initiated exercises in order to see optimum results with regard to muscle strengthening. The use of games or similar methods of engaging a user may be beneficial in that such methods may encourage the user to persist in their exercise program. Various classes of muscle stimulators have been defined by the U.S. Food and Drug Administration including muscle stimulators for the improvement of muscle tone, muscle stimulators for the treatment of incontinence and stimulation for the treatment of muscle pain feedback.
Applications for regulated stimulation and interactive feedback extend beyond the pelvic floor muscles and incontinence issues. Various other muscle groups may be educated and re-educated to perform in desirable ways. Herein, the terms education and re-education may be used interchangeably. Examples of such applications include, but are not limited to, replantation patients, stroke victims, paralysis victims, and individuals experiencing other injuries or conditions. In such cases, the amount of muscle stimulation required for safe and optimal muscle education must be determined and utilized. In many cases, the optimal amount of muscle stimulation is specific to the particular user based on the user's physical characteristics, injury or condition, and progress within the muscle education program. Therefore, what is needed is a system and method which provides regulated muscle stimulation and interactive feedback for muscle education.
A system and method which provides regulated muscle stimulation and interactive feedback for muscle education is disclosed. The muscle education may involve neurological (hypothalamic) and spinal locomotor pattern generation. In an embodiment of such a device and system, a muscle stimulation system may be combined with a biofeedback receiving system that interacts with a plurality of games. A user of such a device may engage the muscle stimulation system to both provide conditioning to pelvic floor muscles and also to learn what sort of muscle response produces the desired conditioning of the pelvic floor muscles. A user may also use the plurality of games to encourage the user to perform exercises to strengthen the pelvic floor muscles. Games may have the benefit of encouraging the user to initiate the desired exercise and also to provide guidance to the user in regards to an optimum exercise level and technique. In an embodiment of the invention, a firewall may be created between the stimulation portion and the feedback portion to prevent the use of the feedback portion to control the stimulation. Such a firewall may be physical in nature, in other words, a physical isolation between the electronic components comprising the stimulation and biofeedback portion of an embodiment of the invention. In other embodiments of the invention, the firewall may be formed by the software programming of the embodiment. In such an example, the software may be designed to prevent interaction between the biofeedback and stimulation portions of the embodiment. In an embodiment of the device in which the firewall is formed in software, an enabling code may be implemented such that persons seeking to change or modify the device programming may be prevented from doing so without having the proper enabling code. Such an enabling code feature may also be used to prevent software modifications or game designs that may be harmful to a user of the device.
The muscle stimulation provided may be regulated to reflect a desired outcome. Too much muscle stimulation can be counter-productive as it may result in regression of muscle education. Too little muscle stimulation may not be sufficient to educate the muscles.
For each individual user the maximum therapeutic efficacy may be achieved by way of an algorithmic demonstration of sufficient muscle performance and respiration. Salient to the multi-variable algorithm is the status of the targeted muscle tissues including, but not limited to, muscle responsiveness to following the requisite task and a determination of blood flow. So, if the muscle is unable to perform specific template driven low level contraction challenges and/or exhibits any indications of spasm as monitored by EMG then the next stimulation (NMES) cycle is blocked and remains arrested for as long as the muscle or muscle group cannot perform the threshold point prequalification parameters. As such, the stimulation to be provided may be determined based on characteristics of the specific individual user.
Alternatively, or in addition, the stimulation to be provided may be determined based on the user's condition or injury. In exemplary embodiments, a visualization tool may be provided with the regulated stimulation. The visualization tool may provide a visualization of the desired outcome during periods of regulated stimulation to incorporate the user's locomotor pattern generation in therapy so as to include but not limited to procedural memory when the pattern of the objects drives action and when that perception is integral to action in the act of mapping the patterns of the world onto the patterns of the body. Alternatively, or in addition, the visualization tool may provide a visualization of the biofeedback received at the device for enhanced precision in developing specific procedural memory tasks for the specific individual user.
Further features and advantages of the devices and systems disclosed herein, as well as the structure and operation of various aspects of the present disclosure, are described in detail below with reference to the accompanying figures.